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Psoriatic ArthritisPhase 3MUSTNCT03148860

Impact of Concomitant MTX on Efficacy, Safety and Adherence of Ustekinumab-treatment in Patients With Active PsA

A Phase 3 study testing Methotrexate and Ustekinumab in people with Psoriatic Arthritis, run by Dr. Frank Behrens at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Methotrexate (MTX) co-medication can improve the therapeutic effect of biological therapies (e.g. Tumor necrosis factor (TNF) -inhibitors) in rheumatoid arthritis (RA), but its role in Psoriatic Arthritis (PsA) remains unclear. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Methotrexate and Ustekinumab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
1 siteGermany
Study dates
15 Dec 2016to 21 Oct 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with active psoriatic arthritis who are naïve to UST will be stratified to either without MTX-therapy or on MTX-treatment (dosage 15mg once weekly) for at least 12 weeks prior to screening.
  • Active PsA is defined as TJC ≥4 and SJC ≥4 (68/66 joint count) and DAS28 ≥ 3,2 at screening
  • PsA according to CASPAR criteria
  • At least age of 18 years
  • Presence of chest x-ray without signs of active or latent infection (esp. for tuberculosis) within the last 3 months
  • Permitted pre-treatment with up to three biologic-agents, whereupon only one biologic agent must be withdrawn due to inadequate response.
Show all 12Show fewer
  • For MTX-naive patients: Previous use of NSAID
  • Written informed consent obtained prior to the initiation of any protocol-required procedures
  • Compliance to study procedures and study protocol Inclusion criteria related to MTX
  • For the group on MTX: Patients must have stable MTX dosages of at least 15mg once weekly for at least 12 weeks prior to screening and stable MTX dosages of at 15mg once weekly for at least 4 weeks prior to screening
  • Compliance of intake of MTX must be documented by treating physician
  • For the group without MTX therapy: patients must be eligible for MTX treatment (according to SmPC) and have not failed prior MTX treatment for the treatment of PsA

Who cannot join

  • Exclusion criteria related to Investigational medicinal product (IMP):
  • Previous use of UST or any other anti-IL23 agent
  • according to SmPC
  • Inadequate Response to prior MTX-treatment for Psoriatic Arthritis
  • previous B-cell depleting therapy
  • Patients with other chronic inflammatory articular disease or systemic autoimmune disease with musculoskeletal symptoms
Show all 33Show fewer
  • Patients with active Tb
  • Patients with latent Tb, measured by Interferon gamma release assay, that are not pre-treated for at least 1 months and planned to be treated 9 months in total with INH once a day according to local guidelines
  • Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
  • Primary or secondary immunodeficiency
  • History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
  • Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
  • History of a severe psychological illness or condition
  • Known hypersensitivity to any component of the product
  • Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test
  • Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier)
  • Alcohol, drug or chemical abuse Exclusion criteria related to prior treatments
  • Previous DMARD therapy other than MTX at least for the last 28 days prior screening due to washout time of different DMARD therapies (including Leflunomide etc.)
  • Previous immunosuppressive biologic therapy at least for the last
  • 4 weeks prior to screening for Enbrel® (etanercept) - with a terminal half-life of 102 ± 30 hours (s.c. route)
  • 10 weeks prior to screening for Humira® (adalimumab) - with a terminal half-life of 10-20 days (average 2 weeks) (s.c. route)
  • 10 weeks prior to screening for Simponi® (golimumab) - with a terminal half-life of 11-14 days
  • 10 weeks prior to screening for Cimzia® (certolizumab) - with a terminal half-life of approx. 14 days
  • 8 weeks prior to screening for Remicade® (infliximab) - with a terminal half-life of 8.0-9.5 days (i.v. infusion)
  • 60 days prior to screening due to washout time of other immunosuppressive biologic therapies
  • current participation in another interventional clinical trial
  • Haemoglobin < 8.5 g / dl
  • Neutrophil counts < 1.500 / μl
  • Platelet count < 75.000 / μl
  • Lower than 1 x 1000 / μl lymphopenia for more than three months prior to inclusion.
  • Serum creatinine > 1.4 mg / dl for women or 1.6 mg / dl for men
  • AST or ALT > 2.5 time upper limit of norm
  • Underage or incapable patients

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CIRI

    Frankfurt am Main, Hessia, 60526

Other trials in Germany

About this study

Official title: Impact of Concomitant Methotrexate on Efficacy, Safety and Adherence of Ustekinumab-treatment in Patients With Active Psoriasis Arthritis

Methotrexate (MTX) co-medication can improve the therapeutic effect of biological therapies (e.g. Tumor necrosis factor (TNF) -inhibitors) in rheumatoid arthritis (RA), but its role in Psoriatic Arthritis (PsA) remains unclear.

No data from Randomized Clinical Trials (RCTs) are available to address the questions whether add-on of MTX to UST monotherapy, or a withdrawal of continuous MTX therapy in patients with newly initiated Ustekinumab (UST) treatment or simultaneously induction of MTX with UST in naive active PsA-patients will influence outcome measurements.

So, the purpose of the study is to analyse the effects of blinded MTX-co-medication on outcome in patients treated with UST: Non-inferiority at week 24 of UST monotherapy compared to add-on to MTX in patients with active PsA and at least 12 weeks of MTX treatment prior to screening or who are actually not treated with MTX and do not have prior inadequate response to MTX-treatment for PsA will be demonstrated.

Read the detailed description

Methotrexate (MTX) co-medication can improve the therapeutic effect of biological therapies (e.g. TNF-inhibitors) in rheumatoid arthritis (RA), but its role in Psoriatic Arthritis (PsA) remains unclear. Differences in phenotypical manifestations between PsA and RA might influence the impact of co-medication, treatment response and treatment adherence differently.

Independent from this data, the impact of use of MTX in Ustekinumab (UST) treated patients with active PsA remains unclear: No data from Randomized Clinical Trials (RCTs) are available to address the questions whether add-on of MTX to UST monotherapy, or the other way around, a withdrawal of continuous MTX therapy in patients with newly initiated UST treatment or simultaneously induction of MTX with UST in patients will influence outcome.

There is some evidence that MTX may contribute to improved treatment persistence with anti-TNF therapy, particularly when used in combination with infliximab, but there is very little data to support a benefit in effectiveness in patients receiving concomitant MTX.

Additionally, MTX may play a role in immunogenicity: In the PSUMMIT program the patients with concomitant MTX had lower anti-drug-antibody (ADA) rates than those on UST-monotherapy, although there was no effect on efficacy and safety.

Furthermore, methotrexate treatment manifestations such as dactylitis or enthesitis seems to be ineffective.

In this study, the effect of blinded MTX-co-medication on outcome in patients treated with UST will be analysed. Differences on efficacy, safety and treatment adherence will be calculated related to MTX use in four arms of the stratified, randomized placebo-controlled clinical trial which contains a study treatment period of 52 weeks. The primary endpoint, differences in DAS28 in the treatment groups, will be measured at week 24.

Being tested
Methotrexate, Ustekinumab, Placebo
Keywords
Psoriatic Arthritis, Ustekinumab, Methotrexate, DAS28
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    subjects will receive once weekly 15 mg (3 capsules) MTX

  • UstekinumabDrug

    Also called Stelara

    subject will receive Ustekinumab open-label over a treatment period of 52 weeks

  • PlaceboOther

    subjects will receive once weekly 3 capsules PLC to MTX

Study groups in NCT03148860
Study groupRoleWhat they receive
Methotrexate naive - Ustekinumab and MethotrexateActive comparatorMethotrexate naive subjects will be randomised to receive Methotrexate or Placebo, Ustekinumab will be given open-label
Receives: Drug: Methotrexate; Drug: Ustekinumab
Methotrexate naive - Ustekinumab and Placebo to MethotrexatePlacebo comparatorMethotrexate naive subjects will be randomised to receive Methotrexate or Placebo, Ustekinumab will be given open-label
Receives: Drug: Ustekinumab; Other: Placebo
Methotrexate pre-treated subjects-Ustekinumab and MethotrexateActive comparatorsubjects pretreated with Methotrexate will be randomised to receive Methotrexate or Placebo, Ustekinumab will be given open-label
Receives: Drug: Methotrexate; Drug: Ustekinumab
Methotrexate pre-treated subjects-Ustekinumab and PLCPlacebo comparatorsubjects pretreated with Methotrexate will be randomised to receive Methotrexate or Placebo, Ustekinumab will be given open-label
Receives: Drug: Ustekinumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of mean values of DAS28 at week 24

    To demonstrate non-inferiority of mean values of DAS28 at week 24 of UST monotherapy compared to add-on to MTX with stratification according to patients on or without MTX before randomization.

    Measured: week 24

Secondary outcomes (68)

  1. Assessment of mean DAS28 at week 52

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: week 52

  2. Assessment of DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: week 4

  3. Assessment of DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: week 16

  4. Assessment of DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: week 24

  5. Assessment of DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: week 40

  6. Assessment of DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: week 52

  7. change in DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: baseline to week 4

  8. change in DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: baseline to week 16

  9. change in DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: baseline to week 24

  10. change in DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: baseline to week 40

  11. change in DAS28

    The Disease Activity Score (DAS) consists of SJC and TJC measurements, the erythrocyte sedimentation rate (or CRP) and the subject's global assessment of disease activity.

    Measured: baseline to week 52

  12. DAS28-ESR remission

    Measured: week 4

  13. DAS28-ESR remission

    Measured: week 16

  14. DAS28-ESR remission

    Measured: week 24

  15. DAS28-ESR remission

    Measured: week 40

  16. DAS28-ESR remission

    Measured: week 52

  17. Assessment of Tender joint count/Swollen joint count (TJC/SJC) (68/66)

    Tender and swollen joint will be assessed and counted by trained personel

    Measured: week 4

  18. Assessment of TJC/SJC (68/66)

    Tender and swollen joint will be assessed and counted by trained personel

    Measured: week 16

  19. Assessment of TJC/SJC (68/66)

    Tender and swollen joint will be assessed and counted by trained personel

    Measured: week 24

  20. Assessment of TJC/SJC (68/66)

    Tender and swollen joint will be assessed and counted by trained personel

    Measured: week 40

  21. Assessment of TJC/SJC (68/66)

    Tender and swollen joint will be assessed and counted by trained personel

    Measured: week 52

  22. ACR (20/50/70) response

    Portion of Patient that reach 20%, 50% or 70% improvement in ACR score consisting of SJC and TJC measurements, subject's assessment of pain, subject's global assessment of disease activity, physician's global assessment of disease activity, HAQ and measurements of erythrocyte sedimentation rate and CRP

    Measured: week 4

  23. ACR (20/50/70) response

    Portion of Patient that reach 20%, 50% or 70% improvement in ACR score consisting of SJC and TJC measurements, subject's assessment of pain, subject's global assessment of disease activity, physician's global assessment of disease activity, HAQ and measurements of erythrocyte sedimentation rate and CRP

    Measured: week 16

  24. ACR (20/50/70) response

    Portion of Patient that reach 20%, 50% or 70% improvement in ACR score consisting of SJC and TJC measurements, subject's assessment of pain, subject's global assessment of disease activity, physician's global assessment of disease activity, HAQ and measurements of erythrocyte sedimentation rate and CRP

    Measured: week 24

  25. ACR (20/50/70) response

    Portion of Patient that reach 20%, 50% or 70% improvement in ACR score consisting of SJC and TJC measurements, subject's assessment of pain, subject's global assessment of disease activity, physician's global assessment of disease activity, HAQ and measurements of erythrocyte sedimentation rate and CRP

    Measured: week 40

  26. ACR (20/50/70) response

    Portion of Patient that reach 20%, 50% or 70% improvement in ACR score consisting of SJC and TJC measurements, subject's assessment of pain, subject's global assessment of disease activity, physician's global assessment of disease activity, HAQ and measurements of erythrocyte sedimentation rate and CRP

    Measured: week 52

  27. Change in ACR core set

    Changes in SJC, TJC, HAQ, patient's and physician's global assessment, pain, CRP and ESR will be described

    Measured: baseline to week 4

  28. Change in ACR core set

    Changes in SJC, TJC, HAQ, patient's and physician's global assessment, pain, CRP and ESR will be described

    Measured: baseline to week 16

  29. Change in ACR core set

    Changes in SJC, TJC, HAQ, patient's and physician's global assessment, pain, CRP and ESR will be described

    Measured: baseline to week 24

  30. Change in ACR core set

    Changes in SJC, TJC, HAQ, patient's and physician's global assessment, pain, CRP and ESR will be described

    Measured: baseline to week 40

  31. Change in ACR core set

    Changes in SJC, TJC, HAQ, patient's and physician's global assessment, pain, CRP and ESR will be described

    Measured: baseline to week 52

  32. Assessment of PASI

    The Psoriasis Area and Severity Index (PASI) is used for evaluation of severity and extend of skin involvement of the included patients

    Measured: week 4

  33. Assessment of BASDAI

    The Bath ankylosing spondylitis disease activity index will be performed for those patients who have radiological findings suspect for axial involvement

    Measured: week 4

  34. Assessment of BSA

    The body surface area will be evaluated to measure the extend of Psoriasis in the included PsA patients.

    Measured: week 4

  35. Assessment of BASDAI

    The Bath ankylosing spondylitis disease activity index will be performed for those patients who have radiological findings suspect for axial involvement

    Measured: week 16

  36. Assessment of PASI

    The Psoriasis Area and Severity Index (PASI) is used for evaluation of severity and extend of skin involvement of the included patients

    Measured: week 16

  37. Assessment of BSA

    The body surface area will be evaluated to measure the extend of Psoriasis in the included PsA patients.

    Measured: week 16

  38. Assessment of BASDAI

    The Bath ankylosing spondylitis disease activity index will be performed for those patients who have radiological findings suspect for axial involvement

    Measured: week 24

  39. Assessment of PASI

    The Psoriasis Area and Severity Index (PASI) is used for evaluation of severity and extend of skin involvement of the included patients

    Measured: week 24

  40. Assessment of BSA

    The body surface area will be evaluated to measure the extend of Psoriasis in the included PsA patients.

    Measured: week 24

  41. Assessment of PASI

    The Psoriasis Area and Severity Index (PASI) is used for evaluation of severity and extend of skin involvement of the included patients

    Measured: week 40

  42. Assessment of BSA

    The body surface area will be evaluated to measure the extend of Psoriasis in the included PsA patients.

    Measured: week 40

  43. Assessment of BASDAI

    The Bath ankylosing spondylitis disease activity index will be performed for those patients who have radiological findings suspect for axial involvement

    Measured: week 40

  44. Assessment of PASI

    The Psoriasis Area and Severity Index (PASI) is used for evaluation of severity and extend of skin involvement of the included patients

    Measured: week 52

  45. Assessment of BSA

    The body surface area will be evaluated to measure the extend of Psoriasis in the included PsA patients.

    Measured: week 52

  46. Assessment of BASDAI

    The Bath ankylosing spondylitis disease activity index will be performed for those patients who have radiological findings suspect for axial involvement

    Measured: week 52

  47. Treatment adherence measured by patient diary

    Compliance with treatment will be determined by patient diary

    Measured: through treatment period; normally 52 weeks

  48. Compliance measured by questionnaire CQR5

    The CQR5 consists of 5 questions addressing information on treatment compliance of the patient.

    Measured: through treatment period; normally 52 weeks

  49. Quality of life measured by HAQ

    Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA

    Measured: week 4

  50. Quality of life measured by EQ5D

    EQ5D is a standardised instrument for use as a measure of health outcome

    Measured: week 4

  51. Quality of life measured by DLQI

    The Dermatology Life Quality Index is a 10-question validated questionnaire.

    Measured: week 4

  52. Quality of life measured by EQ5D

    EQ5D is a standardised instrument for use as a measure of health outcome

    Measured: week 16

  53. Quality of life measured by HAQ

    Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA

    Measured: week 16

  54. Quality of life measured by DLQI

    The Dermatology Life Quality Index is a 10-question validated questionnaire.

    Measured: week 16

  55. Quality of life measured by DLQI

    The Dermatology Life Quality Index is a 10-question validated questionnaire.

    Measured: week 24

  56. Quality of life measured by EQ5D

    EQ5D is a standardised instrument for use as a measure of health outcome

    Measured: week 24

  57. Quality of life measured by HAQ,

    Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA

    Measured: week 24

  58. Quality of life measured by HAQ

    Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA

    Measured: week 40

  59. Quality of life measured by EQ5D

    EQ5D is a standardised instrument for use as a measure of health outcome

    Measured: week 40

  60. Quality of life measured by DLQI

    The Dermatology Life Quality Index is a 10-question validated questionnaire.

    Measured: week 40

  61. Quality of life measured by HAQ

    Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA

    Measured: week 52

  62. Quality of life measured by EQ5D

    EQ5D is a standardised instrument for use as a measure of health outcome

    Measured: week 52

  63. Quality of life measured by DLQI

    The Dermatology Life Quality Index is a 10-question validated questionnaire.

    Measured: week 52

  64. Assessment of Change in Dactylitis

    Functional assessment: Change in number and severity of digits involved) involved

    Measured: week 4, 16, 24, 40 and week 52

  65. Assessment of Change in Enthesitis (LEI)

    functional outcome

    Measured: week 4, 16, 24, 40 and week 52

  66. Assessment of mtNAPSI

    The modified target Nail Psoriasis Severity Index is used for evaluation of nail involvement in patients

    Measured: week 4, 16, 24, 40 and week 52

  67. Ultrasound (US) assessment of joints and enthesis according to PASON22

    selected sites only

    Measured: Week 4, 24 and week 52

  68. Frequency and seriousness of adverse events as reported and documented in Case report form

    Documentation of the occurence, frequency and seriousness of adverse events as reported and documented in Case report form

    Measured: each study visit (week 0 to week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2017
  2. Study start15 Dec 2016
  3. Primary completion12 Apr 2021
  4. Study completion21 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomised, placebo-controlled, double-blind, multicenter study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03148860
Sponsor's protocol ID
TMP-1115_01
Acronym
MUST
Status last verified
Mar 2022
First submitted
4 Apr 2017
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Koehm M, Rossmanith T, Foldenauer AC, Herrmann E, Brandt-Jurgens J, Burmester GR, Kellner H, Kiltz U, Kofler DM, Rech J, Mojtahed-Poor S, Jonetzko C, Burkhardt H, Behrens F; MUST Investigator Group. Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): a randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial. Lancet Rheumatol. 2023 Jan;5(1):e14-e23. doi: 10.1016/S2665-9913(22)00329-0.

    PubMed 38251504

  • Mojtahed Poor S, Henke M, Ulshofer T, Kohm M, Behrens F, Burkhardt H, Schiffmann S. The role of antidrug antibodies in ustekinumab therapy and the impact of methotrexate. Rheumatology (Oxford). 2023 Dec 1;62(12):3993-3999. doi: 10.1093/rheumatology/kead177.

    PubMed 37079726

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methotrexate and Ustekinumab in people with Psoriatic Arthritis, run by Dr. Frank Behrens at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of mean values of DAS28 at week 24 (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03148860, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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